Lead assembly and related methods

ABSTRACT

Defibrillator lead designs and methods for manufacturing a lead having attachment between a fibrosis-limiting material covering, a shocking coil electrode, and an implantable lead body are disclosed herein. An electrode coil fitting is disposed within the shocking coil electrode. In an option, the fibrosis limiting material extends past the ends of the electrode coil, and is wrapped between the coil electrode and the electrode coil member.

RELATED APPLICATIONS

This application is a Divisional application of U.S. patent applicationSer. No. 12/437,519, filed May 7, 2009, which claims the benefit under35 U.S.C. 119(e) of U.S. Provisional Patent Application Ser. No.61/051,261, filed on May 7, 2008, both of which are incorporated hereinby reference in their entireties.

TECHNICAL FIELD

This document pertains generally to implantable defibrillator leads withfibrosis-limiting material.

BACKGROUND

Cardiac and other defibrillation systems typically include animplantable medical device (IMD), such as a pulse generator,electrically connected to the heart by at least one implantabledefibrillator lead. More specifically, an implantable defibrillator leadprovides an electrical pathway between the IMD, connected to a proximalend of the lead, and cardiac tissue, in contact with a distal end of thelead. In such a manner, electrical stimulation (e.g., in the form of oneor more shocks or countershocks) emitted by the IMD may travel throughthe implantable defibrillator lead and stimulate the heart via one ormore exposed, helically wound shocking coil electrodes located at ornear the lead distal end portion. Once implanted, the exposed shockingcoil electrodes often become entangled with fibrosis (i.e., a capsule ofinactive tissue which grows into the exposed coils) with the end resultbeing that a chronically implanted lead can be extremely difficult toremove by the application of tensile force to the lead proximal end.

Over time, situations may arise which require the removal andreplacement of an implanted defibrillator lead. As one example, animplanted defibrillator lead may need to be replaced when it has failed,or if a new type of cardiac device is being implanted which requires adifferent type of lead system. As another example, bodily infection orshocking coil electrode dislodgement may require the replacement of animplanted defibrillator lead. In such situations, the implanteddefibrillator lead may be removed and replaced with one or moredifferent implantable leads.

To allow for easier removal, some implantable defibrillator leadsinclude a fibrosis-limiting material covering a portion of the one ormore otherwise exposed shocking coil electrodes thereon. When subjectedto shear loads, such as during lead implantation procedures, thefibrosis-limiting material may separate from the associated shockingcoil electrode or the shocking coil electrodes themselves may separatefrom the lead body or deform, thereby leaving uncovered coils that aresubject to future fibrotic entanglement.

SUMMARY

Certain examples include a lead comprising a lead body, at least oneshocking coil electrode, and a fibrosis-limiting material. The lead bodyextends from a lead proximal end portion to a lead distal end portionand may optionally include an inner insulating layer and an outerinsulating layer. At least one shocking coil electrode is disposed alongthe lead body, for example, but not limited to, at one or both of thelead intermediate portion or the lead distal end portion. The shockingcoil electrode includes one or more laser welded portions. Thefibrosis-limiting material coaxially surrounds, at least in part, the atleast one shocking coil electrode.

In another example, a lead assembly includes a lead body includingelongate tubing extending from a first end portion to a second endportion and having an intermediate portion therebetween, and at leastone electrode coil disposed along the lead body, the at least oneelectrode coil defined in part by a longitudinal axis and an electrodecoil length. The electrode coil has end portions and an intermediateportion between the end portions. The lead assembly further includes atleast one fibrosis limiting coating including one or more end portions,the one or more end portions disposed along an exterior portion of theat least one electrode coil, and the fibrosis limiting coating having alength longer than the electrode coil length.

In a further example, a method of manufacturing the lead includesforming a lead assembly including coating an external portion of atleast one electrode coil with a coating of fibrosis limiting material,where the coating of fibrosis limiting material extends past endportions of the electrode coil. The method further includes disposingthe electrode coil over an electrode coil fitting and anchoring thefibrosis limiting material between the electrode coil and the electrodecoil fitting, coupling the at least one electrode coil with at least oneconductor, and disposing insulative lead body over at least a portion ofthe at least one conductor and adjacent to the electrode coil andcoating.

These and other examples, advantages, and features of the present leadsand methods will be set forth in part in the detailed description, whichfollows, and in part will become apparent to those skilled in the art byreference to the following description of the present leads, methods,and drawings or by practice of the same.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like numerals describe substantially similar componentsthroughout the several views. Like numerals having different lettersuffixes represent different instances of similar components. Thedrawings illustrate generally, by way of example, but not by way oflimitation, various embodiments discussed in the present document.

FIG. 1 illustrates a schematic view of a cardiac defibrillator system,including an implantable medical device and an implantable defibrillatorlead, as constructed in accordance with at least one embodiment.

FIG. 2 illustrates a plan view of an implantable defibrillator lead, asconstructed in accordance with at least one embodiment.

FIG. 3 illustrates an enlarged cross-sectional view of a portion of animplantable defibrillator lead, such as along line 3-3 of FIG. 2, and animplanted environment, as constructed in accordance with at least oneembodiment.

FIGS. 4A-4E illustrate a side view of a portion of an implantabledefibrillator lead, as constructed in accordance with variousembodiments.

FIG. 5A illustrates a cross-sectional view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 5B illustrates an exploded isometric view of a portion of a lead,as constructed in accordance with at least one embodiment.

FIG. 5C illustrates an isometric view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 5D illustrates an isometric view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 5E illustrates a schematic view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 5F illustrates a schematic view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 5G illustrates a schematic view of a portion of a lead, asconstructed in accordance with at least one embodiment.

FIG. 6 illustrates a schematic view of an implantable defibrillator leadbeing advanced through an introducer sheath (shown in cross-section), asconstructed in accordance with at least one embodiment.

FIG. 7A illustrates a side view of a fitting, as constructed inaccordance with at least one embodiment.

FIG. 7B illustrates a cross-sectional view of a fitting taken along7B-7B of FIG. 7A.

FIG. 7C illustrates a cross-sectional view of a fitting taken along7C-7C of FIG. 7A.

FIG. 7D illustrates an end view of a fitting, as constructed inaccordance with at least one embodiment.

DETAILED DESCRIPTION

The following detailed description includes references to theaccompanying drawings, which form a part of the detailed description.The drawings show, by way of illustration, specific embodiments in whichthe present leads and methods may be practiced. These embodiments, whichare also referred to herein as “examples,” are described in enoughdetail to enable those skilled in the art to practice the present leadsand methods. The embodiments may be combined, other embodiments may beutilized or structural or logical changes may be made without departingfrom the scope of the present leads and methods. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present leads and methods is defined by the appended claimsand their legal equivalents.

In this document, the terms “a” or “an” are used to include one or morethan one, and the term “or” is used to refer to a nonexclusive “or”unless otherwise indicated. In addition, it is to be understood that thephraseology or terminology employed herein, and not otherwise defined,is for the purpose of description only and not of limitation.

FIG. 1 illustrates a schematic view of a cardiac defibrillator system100, which is useful for the correction of tachycardia or fibrillation,among other things. The system 100 includes an implantable medicaldevice 102 and at least one implantable defibrillator lead 104. Asshown, the implantable defibrillator lead 104 includes a lead body 120extending from a lead proximal end portion 106, coupled with theimplantable medical device 102, to a lead distal end portion 108implanted within, on, or near a heart 114, with a lead intermediateportion 116 therebetween. The lead intermediate portion 116 or the leaddistal end portion 108 includes at least one shocking coil electrode110, wherein the at least one shocking coil electrode 110 is defined inpart by a longitudinal axis and an electrode coil length. In thisexample, the at least one shocking coil electrode 110 is at leastpartially surrounded by a fibrosis-limiting material 112. In anotherembodiment, the fibrosis limiting material is disposed on areas wherethe shocking electrode 110 contacts or interacts with tissue or bodilyfluids. In various examples, the fibrosis-limiting material 112comprises a thin, polymeric layer coaxially surrounding and contactingan outer surface 370 (FIG. 3) of the helically wound shocking coilelectrode 110.

The implantable defibrillator lead 104 transmits electrical signalsbetween a selected location within, on, or about the heart 114 and theimplantable medical device 102, such as to monitor the heart's 114electrical activity at the selected location or to carry stimulationsignals (e.g., one or more shocks or countershocks) to the selectedlocation from the implantable medical device 102. The implantabledefibrillator lead 104 may include a fixation assembly, such as one ormore tines 118, or a helical coil, to anchor the lead distal end portion118 at the selected location. The one or more tines 118 may be formed aspart of the lead body 120, and thus may include a biocompatible leadbody material, such as silicone rubber, polyurethane, polyimide, or anon-porous fluoropolymer. The fixation can be an active fixationassembly and/or a passive fixation assembly.

FIG. 2 illustrates a plan view of an implantable defibrillator lead 104,in an option. The implantable defibrillator lead 104 includes a leadbody 120 extending from a lead proximal end portion 106 to a lead distalend portion 108 and having a lead intermediate portion 116 therebetween.In various examples, the lead body 120 includes an inner insulator layer202, such as silicone rubber or other layer of impermeable polymericelectrically insulating material, and/or an outer insulator layer 204,such as polyurethane which provides high abrasion resistance.

In this example, the lead intermediate portion 116 and the lead distalend portion 108 include one or more shocking coil electrodes, such as afirst and a second shocking coil electrode 110. The first and secondshocking coil electrodes 110 include an uninsulated, helically woundshocking coil formed of a non-corrosive, biocompatible metal, such asplatinum, titanium, or alloys (e.g., platinum/iridium). The shockingcoil electrodes 110 are covered by a pliable fibrosis-limiting material112 (e.g., polytetrafluoroethylene (PTFE) or expanded PTFE (ePTFE)) indirect contact with an outer surface 370 (FIG. 3) of the shocking coilelectrode 110. In an option, the fibrosis limiting material 112 is notentirely in direct contact with the coil electrode 110. The implantabledefibrillator lead 104 of this example further comprises an optionaldistal tip electrode 210. The distal tip electrode 210 may be porous andinclude a metallic mesh. One or more conductors in the lead body 120electrically and mechanically couple the electrodes 110, 210 to the leadproximal end portion 106. The conductors may be of any structure orcombination of structures, such as coaxial or coradial coils separatedby an insulating tube, or side-by-side cables or coils separated by apolymer, such as fluoropolymer, silicone, polyimide, or polyurethane.

In an option, the lead proximal end portion 106 includes one or moreterminal leg connections 206 which are sized and shaped to couple torespective connector cavities incorporated into a header of theimplantable medical device 102 (FIG. 1). It is through the couplingbetween the lead proximal end portion 206 and the connector cavitiesthat the electrodes 110, 210 are electrically coupled to electroniccircuitry within the implantable medical device 102. While FIG. 2illustrates an implantable defibrillator lead 104 having three terminalconnections 206 and three electrodes 110, 210, the present leads mayvary, such as by including more or less than three terminal connections206 and electrodes 110, 210.

FIG. 3 illustrates an enlarged cross-sectional view, such as along line3-3 of FIG. 2, of a shocking coil electrode 110 surrounded by a thin,fibrosis-limiting material 112. As shown in this example, thefibrosis-limiting material 112 may be drawn into the coil gaps 302, suchas via a heat sintering process, thereby eliminating or reducing the airvolume present in the gaps. This tight conformation between thefibrosis-limiting material 112 and the shocking coil electrode 110results in good electrical energy transmission 350 from the coil 110 tosurrounding cardiac tissue. The use of the fibrosis-limiting material112 as the tissue contacting portion of the shocking coil electrode 110assists in preventing fibrotic tissue ingrowth.

Options for the fibrosis-limiting material 112 are as follows. Forinstance, the fibrosis-limiting material 112 may include PTFE, ePTFE, orother non-biodegradable and biocompatible materials, such as expandedultra-high molecular weight polyethylene (eUHMWPE); may either be porousor non-porous; or may be inherently conductive or rely on porosity inconjunction with bodily fluids to be conductive. In various porousexamples, the pore size is adequately small to allow penetration ofconductive bodily fluids while substantially precluding tissue ingrowth,thus allowing a less traumatic removal of the defibrillator lead 104after implantation should extraction become necessary. In various otherexamples, electrical conductivity through the fibrosis-limiting material112 is not based on porosity, but rather is inherent in the material112. For example, the fibrosis limiting material 112 is such that it cantransfer electrical energy from the surface of the underlying electrodecoil to the cardiac tissue it is in contact with. At least a portion ofthe outer surface of this material 112 is adapted to stimulate cardiactissue, by being inherently electrically conductive, without relying onporosity and body fluid for charge transfer. The material 112 serves asthe substrate for providing an electrically conductive path by way ofeither any suitable electrically conductive coatings deposited on thepolymer surface, or any suitable electrically conductive particlesblended with the polymer, prior to converting it to the final form.Examples of the substrate polymers include but are not limited tosilicone rubber, polyurethane, and homopolymers or copolymers ofpolyolefin, fluoropolymer, polyamide and polyester. Examples ofelectrically conductive coatings on these polymers include but are notlimited to coatings based on platinum, palladium, iridium, cobalt,silver, nickel and combinations thereof. Such coatings may be depositedby any methods commonly used in the industry, such as electrodelessdeposition, plasma deposition, sputtering or chemical vapor deposition.In a further example, the fibrosis-limiting material 112 is wrappedaround the coil electrode, for example, out of one or more strands ofmaterial.

Turning now to FIGS. 4A-4E, various techniques for manufacturing a leadhaving fibrosis-limiting material 112 are disclosed. These figuresillustrate a side view of a portion of an implantable defibrillator lead104, such as a shocking coil electrode 110, and a fibrosis-limitingmaterial 112.

In an option, the shocking coil electrode 110 includes at least onelaser weld portion 420. The at least one laser weld portion 420 isformed, for example, by laser welding the shocking coil electrode 110,for example, with a laser band that extends 360 degrees around theshocking coil electrode 110. In another option, the laser band onlyextends around a portion of the coil electrode 110. In an option, the atleast one laser weld portion 420 is included at one or more end portions113 of the shocking coil electrode 110. In a further option, the laserweld portion is formed on one or more filars of the shocking coilelectrode 110. For example, the laser weld portion is formed, in anoption, two or more filars of the shocking coil electrode 110, and inanother option on 8-12 filars of the shocking coil electrode 110. Inanother option, about 5 mm of the shocking coil electrode 110 is formedinflexible, for example with the laser weld. In a further option, thefilars are close wound coils. In a further option, multiple portions ofthe shocking coil electrode 110 can include laser weld portions 420,such as shown in FIGS. 4A, 4B, and 4C. For instance, the laser weldportions 420 can be helically disposed about the coil 110, and/ormultiple discrete portions can be disposed about the coil 110.

In an option, end portions of the shocking coil electrode 110 includethe laser weld, and additional discrete portions include the laser weldportion 420. The laser weld portions 420 can extend partially around theshocking coil electrode 110, or can extend 360 degrees around theshocking coil electrode 110. In a further option, for instance as shownin FIG. 4C, multiple discrete laser weld portions 420 can be included ina pattern along the shocking coil electrode 110, or can be randomlydisposed along the shocking coil electrode 110.

The fibrosis-limiting material 112 coaxially covers the shocking coilelectrode 110 and the laser weld portions 420 in a tightly conformingmanner, in an option, and the laser weld portion 420 improves adhesiveof the fibrosis limiting material 112 to the shocking coil electrode110. For instance, the laser weld creates a relatively smooth surfacefor the fibrosis limiting material to attach to. In an option, thefibrosis-limiting material 112 extends to the ends of the shocking coilelectrode 110. In a further option, the fibrosis limiting material 112extends to less than a length of the shocking coil electrode 110.

In yet another option, the fibrosis limiting material 112 has a lengththat is greater than a length of the shocking coil electrode 110. Forinstance, one or more end portions 115 of the fibrosis limiting material112 is able to cover the shocking coil electrode 110 and extend past theend portion 113 of the shocking coil electrode 110. This allows for thefibrosis limiting material 112 to be wrapped around end portions 113 ofthe shocking coil electrode 110, as further discussed below. In anotheroption, a portion of the fibrosis limiting material 112 includes anopening 109 which overlaps, or is disposed over at least a portion ofthe shocking coil electrode 110. The opening 109 allows for access tothe shocking coil electrode 110, without giving up the advantages ofhaving the fibrosis limiting material 112 disposed on the shocking coilelectrode 110.

In an option, the opening 109 has a shape such as, but not limited to,oval, circular or semicircular shape. In a further option, the opening109 allows for a laser to access the shocking coil electrode 110, andallows for a weld to be made on the shocking coil electrode 110, whilethe fibrosis limiting material 112 is disposed on, over, or adjacent tothe shocking coil electrode 110. The opening 109 can be formed bystamping, burning, cutting etc., and/or one or more openings can beformed in the fibrosis limiting material 112. In a further option, thefibrosis limiting material 112 has one or more slits 119 formed in oneor more end portions 115. The slits can be formed with or without theopening 109. In an option, the slit extends from the end of the material112 to a portion near the transition where the electrode 110 and thematerial 112 has a smaller diameter, as illustrated in FIG. 4E. The oneor more slits 119 allow for the fibrosis limiting material 112 forforming of tethers on the material 112, which allows for the material112 to be wrapped around the coil 110. Having the slit extend along thecoil 110 also allows for laser banding of the coil.

In a further option as shown in FIG. 4D, a laser weld portion 420 is atone more end portions 113 of the shocking coil electrode 110, and in anoption is at each of the end portions 113 of the shocking coil electrode110. The laser weld portion 420 includes at least one slit 422 therein,and in an option the at least one slit 422 is provided at each of theend portions 113. In an option, the at least one slit 422 includes twoslits formed, for example, on opposite sides of the shocking coilelectrode 110. The slit 422 allows for the shocking coil electrode 110and/or the laser weld portion 420 to radially expand, for example, by0.005-0.010 inches. For instance, the end portions 113 of the shockingcoil electrode 110 have a larger inner diameter than an intermediateportion of the shocking coil electrode 110.

Referring to FIGS. 4D and 5A, the fibrosis-limiting material 112 isdisposed over the laser band portion 420 and the shocking coil electrode110 after the at least one slit 422 is formed in the laser band portion420. The shocking coil electrode 110 can be expanded to fit over afitting 424 via the at least one slit 422, and the expanded shockingcoil electrode 110 puts radial tension in the fibrosis-limiting material112, such as ePTFE, and increases resistance of movement of thefibrosis-limiting material 112 relative to the shocking coil electrode110, and/or increases the adhesion between the fibrosis limitingmaterial and the shocking coil electrode 110.

FIGS. 7A-7D illustrate various views of the fitting and illustrate thefitting 424 in greater detail. In an option, the fitting 424 generallyhas a cylindrical shape and is sized to be positioned within theshocking coil electrode 110 (FIG. 5A), and is defined in part by anexterior surface 444. In an option, the fitting 424 includes aprojection 446 extending outwardly from the exterior surface 444, suchas an annular projection that extends around a perimeter of the fitting424. The projection 446, in a further option, can have other shapes ordoes not necessarily extend entirely around the perimeter of the fitting424.

In a further option, the fitting 424 includes at least one through hole448 therealong, or multiple through holes 448. For instance, two or morethrough holes 448 are disposed on either side of the projection 446. Ina further option, three or more through holes 448, or four through holes448 are included. The through hole 448 allows for tubing external to thefitting 424, for instance tubing disposed on exterior surface 444, tocontact tubing disposed internal to the fitting. In yet another option,the coil electrode fitting 424 includes conductor attachment features.For instance, in an option, the conductor attachment features includesat least one lumen 450 (FIG. 7D) where the conductor can be disposed andattached therein.

FIGS. 5A-5G illustrate various options for manufacturing the lead whichinclude the fibrosis limiting material 112 includes one or more endportions 115 that extend around end portions 440 of the shocking coilelectrode 110, allowing for the fibrosis limiting material 112 to beanchored between the fitting 424 and the electrode coil 110. FIGS. 5B-5Dillustrate an assembly including a coil fitting 424, a coated electrode110, and a ring 425. The ring 425 includes an opening 426, and the ringis placed on the fitting 424. The coil fitting 424 receives the coatedcoil electrode 110 an external surface 444 thereof. Portions 115 of thefibrosis limiting material 112 are disposed between an interior surface442 of the coil and an exterior surface 444 of the fitting 424, as canbe seen in FIG. 5A. In yet another option, the fibrosis limitingmaterial 112 includes an opening such as a cut out 454, where materialis removed from the coating of fibrosis limiting material 112 so thatthe electrode coil 110 can be welded in the cut out 454. The ring 425,in an option, is slid toward the coil 110 and the opening 426 issubstantially aligned with the opening 450.

In a further option, the fibrosis limiting material 112, in an option,includes one or more tethers 452, as shown in FIGS. 5E-5G. The tethers452 are formed by cutting portions 115 of the fibrosis limiting material112, where the portions 115 allow for the fibrosis limiting material 112to extend to a length longer than the coil electrode 110, which allowsfor the tethers to be disposed between the exterior surface of thefitting 424 and an interior portion 442 of the electrode coil 110, asshown in FIG. 5F. In an option, two or more tethers 452 are formed oneach end portion of the fibrosis limiting material 112, or in a furtheroption three or more tethers 452 are formed on each end portion of thefibrosis limiting material. In an option, the tethers 452 are taperedfrom a relatively wide portion to a narrower portion, as shown in FIG.5E. In another option, the tethers 452 have substantially uniform width.The tethers can be formed by slitting the material, for example as shownin FIG. 4E. In a further option, the coil electrode 110 includes acorresponding number of welded portions to the number of tethers.

In yet another option, the electrode coil 110 can be coated withfibrosis limiting material 112. Portions of the electrode coil 110 canbe removed, for example, by peeling back the coating and cutting thecoil to create a coil 110 having a shorter length than a length of thecoating of fibrosis limiting material 112. This allows for the fibrosislimiting material 112 to be wrapped around end portions of the electrodecoil 110 as discussed above and below. In a further option, theelectrode coil 110 includes end portions which have an expanded outerdiameter relative to an intermediate portion of the electrode coil 110,as shown in FIG. 4E. The fibrosis limiting material 112 conforms to theexpanded coil 110.

Implantable defibrillator leads 104 are placed in contact with cardiactissue by passage through a venous access, such as the subclavian vein,the cephalic vein, or one of its tributaries. In such a manner, animplantable defibrillator lead 104 may advantageously be placed incontact with the heart 114 (FIG. 1) without requiring major thoracicsurgery. Instead, an implantable defibrillator lead 104 may beintroduced into a vein and maneuvered therefrom into contact with theheart 114 or tissue thereof. A multi-step procedure is often required tointroduce implantable defibrillator leads 104 within the venous system.Generally, this procedure consists of inserting a hollow needle into ablood vessel, such as the subclavian vein. A guide wire is then passedthrough the needle into the interior portion of the vessel and theneedle is withdrawn. As illustrated in FIG. 6, an introducer sheath 600with a dilator assembly 602 may be inserted over the guide wire into thevessel for lead 104 introduction. The sheath 600 is advanced to asuitable position within the vessel, such that a distal end thereof iswell within the vessel, while a proximal end thereof is outside thepatient.

When a physician implants a defibrillator lead 104, such as through theintroducer sheath 600 and specifically an introducer seal 604, high dragforces may be created along the lead body 120. As a result of these highdrag forces, previous lead component interfaces including thefibrosis-limiting material 112 to shocking coil electrode 110 and theshocking coil electrode 110 to the lead body 120 could separate or shiftrelative to one another leaving uncovered coil portions subjected tofuture fibrotic entanglement (e.g., the shocking coil electrode 110became stretched, which in turn pulled the fibrosis-limiting material112 away from the coil 110 and exposed a portion of the coil to fibroticgrowth). Using the present lead manufacturing technologies, it has beenfound that such separating or shifting between the fibrosis-limitingmaterial 112, the shocking coil electrode 110, and the lead body 120 isreduced or eliminated, thereby preventing fibrotic entanglement andfacilitating lead extraction should it become necessary. The electrodecoil 110 and the fibrosis-limiting material 112 of the lead 104 canwithstand a drag force of about 0.5 to 1.0 pounds.

A method of manufacturing an implantable defibrillator lead includingrobust attachment between a fibrosis-limiting material, a shocking coilelectrode, and a lead body is described herein. The lead assembly isformed including coating an external portion of at least one electrodecoil with a coating of fibrosis limiting material, where the coating offibrosis limiting material extends past end portions of the electrodecoil. The fibrosis-limiting material is formed onto an outer surface ofthe at least one shocking coil electrode, such as through the use ofheat. Further methods for manufacturing the fibrosis-limiting materialand/or applying the fibrosis-limiting material to the electrode can beused. In an example, the fibrosis limiting material 112 includes PTFEnonwoven web. In an example, to manufacture the PTFE nonwoven web, aPTFE powder is made into a paste, and molded. In another example, theporous thin film covering includes a thin, high strength, stretched,nonwoven web of polytetrafluoroethylene which is composed of nodesinterconnected by fibrils. In another option, the fibrosis limitingmaterial 112 is applied using a wrapping process, such as with a filmwrapping machine. Various options can be used as the film is wrapped.For instance, the film can be wrapped at a certain angle, or a number ofpasses can occur. After the wrapping process, the assembly of the coilelectrode and the fibrosis limiting material 112 can be heated,resulting in the film layers adhering together, and the material 112 iscontracted on to the coil electrode 110.

Optionally, the method further includes laser welding at least a portionof at least one electrode coil, for example, but not limited to at oneor more ends of the coil, and/or at one or more discrete locations ofthe coil, and/or helically along the coil, and/or around 360 degreesaround the coil. The laser welding can be done in the variousembodiments discussed above, and/or illustrated in the drawings. In afurther option, one or more slits are formed in the laser weldedportions, such as at one or each of the end portions of the coil, forexample with two slits. The laser welding can occur prior to coating theelectrode coil.

In a further option, the electrode coil is disposed over an electrodecoil fitting, where the fitting is within the electrode coil, and thefibrosis limiting material is anchored between the electrode coil andthe electrode coil fitting. For instance, end portions of the coating offibrosis limiting material are disposed within the electrode coil. In afurther option, a portion of the fibrosis limiting material is removedso that the electrode can be welded to the fitting. In yet anotheroption, at least one through hole is formed through the fitting, andoptionally tubing on an external portion of the fitting can makecontact, such as adhesive contact, with tubing in the fitting, such as amulti-lumen tubing. In yet another option, one or more tethers areformed in the fibrosis limiting material and are tucked between anexterior surface of the electrode fitting and an interior portion of theat least one electrode coil. At least one conductor is electricallycoupled with the electrode coil. One or more portions, such as endportions, of the at least one shocking coil electrode are coupled to alead body or component. Optionally, the coupling between the shockingcoil electrode and the lead body includes the use of an adhesive.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For instance, any of theaforementioned examples may be used individually or with any of theother examples. In addition, the aforementioned examples may or may notinclude the use of adhesives (e.g., medical adhesives) for selectedcomponent attachment. Many other embodiments may be apparent to those ofskill in the art upon reviewing the above description. The scope of thepresent leads and methods should, therefore, be determined withreference to the appended claims, along with the full scope of legalequivalents to which such claims are entitled. In the appended claims,the terms “including” and “in which” are used as the plain-Englishequivalents of the respective terms “comprising” and “wherein.” Also, inthe following claims, the terms “including” and “comprising” areopen-ended, that is, a system, assembly, article, or process thatincludes elements in addition to those listed after such a term in aclaim are still deemed to fall within the scope of such claim.

The Abstract of the Disclosure is provided to comply with 37 C.F.R.§1.72(b), requiring an abstract that will allow the reader to quicklyascertain the nature of the technical disclosure. It is submitted withthe understanding that it will not be used to interpret or limit thescope or meaning of the claims. In addition, in the foregoing DetailedDescription, various features may be grouped together to streamline thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed embodiments require morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter may lie in less thanall features of a single disclosed embodiment. Thus the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

What is claimed is:
 1. A method comprising: forming a lead assemblyincluding coating an external portion of at least one electrode coilwith a coating of fibrosis limiting material, where the coating offibrosis limiting material extends past end portions of the electrodecoil; disposing the electrode coil over an electrode coil fitting andanchoring the fibrosis limiting material between the electrode coil andthe electrode coil fitting; coupling the at least one electrode coilwith at least one conductor; and disposing insulative lead body over atleast a portion of the at least one conductor and adjacent to theelectrode coil and coating.
 2. The method as recited in claim 1, whereinanchoring the fibrosis limiting material includes disposing coating endportions of the coating of fibrosis limiting material within theelectrode coil.
 3. The method as recited in claim 1, further comprisingforming at least one through hole through the coil electrode fitting. 4.The method as recited in claim 3, further comprising contacting tubingexternal to the electrode coil fitting with internal tubing through theat least one through hole.
 5. The method as recited in claim 1, furthercomprising forming one or more tethers along one or more end portions ofthe fibrosis limiting coating, and disposing the one or more tethersbetween an exterior surface of the at least one coil electrode fittingand an interior portion of the at least one electrode coil.
 6. Themethod as recited in claim 1, further comprising welding the electrodecoil.
 7. The method as recited in claim 6, wherein welding the at leastone electrode coil includes laser welding one or more end portions ofthe at least one electrode coil.
 8. The method as recited in claim 7,further comprising forming at least one slit in the welded portions.